Betamox 150 mg/ml Suspension for Injection

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Amoxicillin

Commercializzato da:

Norbrook Laboratories Limited

Codice ATC:

QJ01CA04

INN (Nome Internazionale):

Amoxicillin

Dosaggio:

150 milligram(s)/millilitre

Forma farmaceutica:

Suspension for injection

Tipo di ricetta:

POM: Prescription Only Medicine as defined in relevant national legislation

Gruppo terapeutico:

Cattle, Pigs, Sheep

Area terapeutica:

amoxicillin

Indicazioni terapeutiche:

Antibacterial

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

1987-10-01

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Betamox 150 mg/ml Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
150 mg amoxicillin (as Amoxicillin Trihydrate), and 0.08 mg butylated
hydroxytoluene (E321) and 0.08 mg butylated
hydroxyanisole (E320) as antioxidants.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
An off-white suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, Sheep, Pigs, Dogs, Cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections caused by a wide range of
Gram-positive and Gram-negative pathogenic bacteria including:
_Bacillus anthracis_
_Haemophilus_ spp.
_Bacillus cereus_
_Pasteurella_ spp.
_Bordetella bronchiseptica_
_Proteus mirabilis_
_Clostridium spp._
_Salmonella_ spp.
_Corynebacterium spp_.
non-penicillinase producing
_Erysipelothrix rhusiopathiae_
Staphylococci
_Escherichia coli_
non-penicillinase producing
_Fusiformis_ spp.
Streptococci
4.3 CONTRAINDICATIONS
Not for intravenous or intrathecal use
Do not use in rabbits, hamsters, gerbils and guinea pigs
Do not use in sheep producing milk for human consumption.
Do not use in known cases of hypersensitivity to
amoxicillin/penicillin.
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4.4 SPECIAL WARNINGS FOR EA